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Tyrosine Kinase Inhibitor

Dasatinib for Pediatric Leukemia

Phase 2

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed, treatment naive CP-CML (Cohort 3)

CP-CML who prove resistant or intolerant to imatinib (Cohort 1)

Must not have

Prior therapy with Dasatinib

Target Population for the PK substudy subjects are not allowed to use proton pump inhibitors, H2 antagonists, CYP3A4 inhibitors and inducers when entering the PK substudy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of dasatinib in children and adolescents with leukemia who either have not responded to or cannot tolerate imatinib.

Who is the study for?

This trial is for children and adolescents with newly diagnosed chronic myeloid leukemia (CML) or Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to imatinib. Participants must have a life expectancy of at least 12 weeks, good liver and kidney function, and provide written consent. They should not have symptomatic CNS involvement, prior dasatinib therapy, or be on certain other medications.

What is being tested?

The study tests the safety and effectiveness of dasatinib in young patients with various phases of CML or ALL who can't use imatinib. It includes three cohorts: those new to treatment, those resistant/intolerant to imatinib, and a pharmacokinetics substudy group analyzing drug levels in the body.

What are the potential side effects?

Possible side effects of dasatinib include immune system suppression leading to increased infection risk; digestive issues like nausea; potential liver toxicity; headaches; skin rashes; fluid retention around eyes or lungs; muscle pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have just been diagnosed with chronic myeloid leukemia and haven't started treatment.

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I have CML and cannot tolerate or didn't respond to imatinib.

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I can do most activities but need help with some.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with Dasatinib before.

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I am not using proton pump inhibitors, H2 antagonists, or CYP3A4 modifiers.

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My cancer is located outside the bone marrow.

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I am eligible for a treatment that could potentially cure my condition, including a stem cell transplant.

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I have symptoms from my brain or spinal cord involvement, not from leptomeningeal disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Cytogenetic Response (CCyR) Rate

Complete Hematologic Response (CHR) Rate

Major Cytogenetic Response (MCyR) Rate

Secondary study objectives

Complete Cytogenetic Response (CCyR) Rate up to 2 Years

Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3

Complete Molecular Response (CMR) Rate

+15 more

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT03023046

26%

Febrile neutropenia

17%

Sepsis

Mucositis oral

Upper gastrointestinal hemorrhage

Hypotension

Hypertension

Intracranial hemorrhage

Enterocolitis

Peripheral motor neuropathy

Small intestinal obstruction

Lower gastrointestinal hemorrhage

Fungemia

Typhlitis

Oropharyngeal pain

Multi-organ failure

Abdominal pain

Hypoxia

Kidney infection

Edema limbs

Sinus bradycardia

Gastric hemorrhage

Myocardial infarction

Diarrhea

Fibrinogen decreased

Aspiration

Atrial fibrillation

Delirium

Endophthalmitis

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3: Newly diagnosed, treatment naïve CP-CMLExperimental Treatment1 Intervention

Dasatinib 60 mg/m² tablet QD \[with a maximum dose of 100 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² PFOS QD \[with a maximum dose of 120 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

Group II: Cohort 2: Ph+ALL or AP- or BP-CMLExperimental Treatment1 Intervention

Dasatinib 80 mg/m² tablet QD \[with a maximum dose of 140 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 96 mg/m² PFOS QD \[with a maximum dose of 170 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

Group III: Cohort 1: Imatinib-resistant/intolerant CP-CMLExperimental Treatment1 Intervention

Dasatinib 60 mg/m² tablet every day (QD) \[with a maximum dose of 100 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² powder for oral suspension (PFOS) QD \[with a maximum dose of 120 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dasatinib

2012

Completed Phase 3

~2320

0 / 8Eligibility criteria met